Clinical Laboratory Molecular Diagnostics Test using inVivoScribe reagents kit.

Description

General Information Document Type: Presolicitation Synopsis Number: 75N98026Q00654 Posted Date: June 17, 2026 Original Response Date: June 29, 2026 Current Response Date: June 29, 2026 Set Aside: N/A NAICS Code: 541990 Contracting Office Address National Institutes of Health (NIH), Office of the Director (OD) Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM) Hospital and Laboratory Support Division 6701 Rockledge Drive Bethesda, MD 20817 Description INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to: Invivoscribe, Inc. 10222 Barnes Canyon Road Building 1 San Diego, CA 92121 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 with a Size Standard $19,500,000. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01, March 13, 2026. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($350,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION Title: Clinical Laboratory Molecular Diagnostics Test using inVivoScribe reagents kit. Background Information: The Molecular Diagnostics Laboratory of the Laboratory of Pathology performs molecular testing to assist in the diagnosis of a variety of cancers. The laboratory develops tests that assist in pathologic diagnosis, predict prognosis and identify potential targets for rational personalized therapies. It is currently the only CLIA and College of American Pathology approved clinical laboratory within the NCI certified for performing molecular oncology testing on materials from NIH patients. InvivoScribe IgH +IgK B-cell clonality Assays is for identification of clonal immunoglobulin heavy chain and kappa light chain gene rearrangement, which are useful for the detection of variety B-cells malignancies, lineage determination of leukemias and lymphomas, monitoring and evaluation of disease recurrence, detection and assessment of residual disease in cancer patients. Specimen Size Control Ladder is for identifying the amplifiable fragmented DNA in the sample, which is useful to determinate the quality of each patient DNA sample. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by June 29, 2026 at 9:00 AM Eastern time and must reference solicitation number 75N98026Q00654. Responses may be submitted electronically to Mr. James Law, Contracting Officer at James.Law@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.�